Federal regulations hound animal research

In the 1990s, Yale School of Public Health professor Leonard Munstermann stumbled through the forests of Central and South America, capturing mosquitoes to use in his experiments. Now, he only deals with dead mosquitoes at the University — partly because of his changing interests, but also because of the thicket of regulations on the use of live specimens.

Though mosquitoes are among the least protected of research animals, Munstermann said he simply did not want to deal with the paperwork anymore.

Jharrett Bryantt

The IACUC requires that researchers fill out several pages of paperwork before they begin testing on animals.

Jharrett Bryantt

Some Yale researchers think that strict regulations on animal testing waste time and discourage innovative experiments.

Since Congress passed the Animal Welfare Act in 1966, increasingly stringent restrictions on animal experimentation have forced researchers to overcome a growing number of barriers to use live animals, six Yale researchers said. Although the legislation protects animals and helps researchers use fewer animals in experiments, many researchers said they believe the paperwork is a burden that can stall scientific progress.

BURIED UNDER PAPERS

Though the federal regulations — enforced by Yale’s Institutional Animal Care and Use Committee (IACUC), a federally-mandated committee that oversees animal research at the University — are sometimes time-consuming for researchers, scientists who flout the laws have their research discredited, said University spokesman Robin Hogen ’70.

“[Regulations] protect the welfare of animals and the integrity of the research,” Hogen said.

Within the past six months, Yale has been evaluated by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a non-profit organization that monitors animal research, Hogen said, and the University received high marks.

While researchers necessarily adjust to the ever-growing amount of paperwork — the Animal Welfare Act has been amended six times since it was first passed — it is an unnecessary, time-consuming portion of research, they said. Anesthesiology professor Chao Ma said Yale researchers may spend up to three weeks explaining the need for their experiment to the IACUC, cutting into the time they could have spent on research.

In order to use animals in research or teaching, researchers must fill three or four forms — some of which are 20 pages long — downloadable from the IACUC Web site. There are also over 50 guidelines. For example, a scientist cannot snip more than five millimeters of tail from a mouse, which must be 10 to 21 days old. At the School of Medicine, dogs older than 12 weeks must receive at least 10 minutes of exercise daily throughout the week and five minutes of exercise daily on weekends and holidays.

To study alewives — a fish found on the Atlantic coast whose numbers have dwindled drastically in recent years — ecology and evolutionary biology professor David Post had to spend a “good chunk” of a week filling out paperwork. Because Post primarily observes the alewives, he said his paperwork was processed by the IACUC relatively quickly. But for researchers that work on animals bred for research such as mice, the process is even more tedious, Post said. Although Post has worked well with the IACUC and understands the importance of the committee, he said he would prefer not to have to deal with them.

A neurobiology and psychology professor at the Yale School of Medicine, who wanted to remain anonymous to protect his research, said while the IACUC requires researchers to submit their protocol for dealing with animals in experiments only once every three years, IACUC officials — many of whom are not researchers — force professors to arbitrarily revise the same protocols they approved three years earlier to “justify [the officials’] existence.” The administrative burden of renewing protocols has prevented him from pursuing new, more innovative experiments, he added.

School of Medicine professor Michael Crair, who works with rats on a variety of experiments, agreed that the regulations have the potential to discourage scientists from working with animals. He added that he was often frustrated by the “lengthy, cumbersome and seemingly pointless” paperwork for the IACUC’s approval process. The IACUC declined to comment.

Alan Goldberg, the chairman of Johns Hopkins University’s Center for Alternatives to Animal Testing and a former IACUC committee member at other institutions, said the amount of time that Post and other professors spent on their paperwork was exceptional. Most investigators can fill most of the forms in less than an hour, he said — a claim that several Yale professors said they disagreed with.

“[At Yale], normally protocol and forms take a couple of weeks,” said Ma, the anesthesiology professor.

Regardless of how long the paperwork actually takes to file, researchers should be ashamed of complaining about having to fill out forms to “torture animals,” said Justin Goodman, a research associate supervisor for People for the Ethical Treatment of Animals (PETA).

“I wish there were an insurmountable amount of paperwork that would prohibit animal experiments in general,” Goodman said.

IS ANIMAL TESTING NECESSARY?

Because of the controversy surrounding animal testing, some researchers have discontinued their previous work on primates, cats and dogs, said anesthesiology and neurobiology professor Robert LaMotte.

“People feel that the research is wrong, but [they] benefit from the research,” LaMotte said.

Many major breakthroughs in medical research have resulted from animal experimentation. In 1921, the invention of insulin was made possible by experiments on dogs, and in 1941, the antibiotic effects of penicillin was discovered by research on mice. Furthermore, the Food and Drug Administration requires drugs to be tested in animals before being tested in humans.

Although researchers would be open to alternatives to animal testing, Crair said he cannot rely on computer simulations to study living beings.

“Studying how the brain works without using ‘live specimens’ would be like trying to understand photosynthesis without using live plants,” he said. “You may be able to make some guesses, but you’re surely going to miss essential aspects of the underlying science.”

On the plus side, because researchers need to justify the use of every animal, the regulations also reduce the costs of experiments. The regulations also encourage researchers to train undergraduates to better care for research animals, he added.

While the federal regulatory system for animal research has worked well for the past four decades, improvements can still be made, said Goldberg, the former IACUC committee member. One of the major flaws of the Animal Welfare Act — which was last amended in 2007 — is that rats, mice and birds are not considered animals under the law, he said. Although the Public Health Service Act, first passed in 1944, covers all research animals, it only applies if public funds are used. Goldberg said he would like to see the Animal Welfare Act cover all species used in research.

Kathleen Conlee, a director of the Humane Society of the United States, an animal advocacy organization, said her organization is lobbying for the U.S. Department of Agriculture to streamline the IACUC’s review process by creating a system that would allow the committees to focus on experiments that cause the most suffering to animals, decreasing the time needed to review monitoring studies similar to Post’s alewives.

But PETA representative Goodman said IACUC has consistently failed at protecting the welfare of animals, and any regulation will continue to provide researchers with a legal “cloak of legitimacy” that protects their studies, he added.

“Ultimately, no amount of oversight or rubber-stamping changes the fact that animal testing treats [living creatures] like disposable lab equipment,” he said.

According to the Humane Society of the United States, there are 18 animal research facilities in Connecticut.

Comments

Med School Grad Student

Far too often are animals abused and disposed of just to “get ahead” of the research game, i.e. to get a new publication (with questionable impact). The first thing that (such talented) researchers can do is find ways to design their methods to reduce the use of animals. I wish the IACUC would provide months in delays… at some point, Profs/Grad Students will finally seriously begin to consider alternatives.

kwadsworth

I find it quite troubling that this Yale researcher Munstermann now works with dead mosquitoes, due to the regulatory paperwork involved in using live mosquitoes. Mosquitoes are NOT under the purview of IACUCs, which only review research with vertebrate animals. I agree with Alan Goldberg that the current regulations have far too many loopholes, but the trend now is for IACUCs to treat all vertebrates with the same high standards to eliminate *discrimination* between species.

Yes, animal research is highly regulated – and I wouldn’t have it any other way, but the characterization of IACUCs as “rubber stamp” is quite outdated. IACUCs are subject to intense oversight, both at the federal and local level, but more importantly, by the public at large. The public relies on us to ensure that animals used in research are use only when alternatives are not available, and then used with the greatest of care and consideration.

Paul M. Stein, an IACUC Chair in a distant land

The problem appears to be with the way the Yale IACUC operates, not with the fact that an IACUC needs to be in place or that the Animal Welfare Act needs to be adhered to. The Yale IACUC system of study approval and oversight needs to be overhauled to eliminate its truly cumbersome nature.

Scientists and IACUC officials and members must get together to figure this thing out. It will take loads of time and effort, but the outcomes will be worth it for all. Start with your forms, line by line, and go from there.

Science Grad Student

I find it absolutely absurd that these researchers complain so much about regulations which are basically nothing but formalities.

As a graduate student in the sciences (but not involved myself in animal research), I have heard many stories about researchers ‘working around’ IACUC regulation, hiding true lab conditions from inspectors and in general doing the bare minimum to demonstrate compliance.

While it is true that animal research has and will continue to lead to important discoveries, personally I would like to see a much higher bar set for the use of animals in research – many times animals are used for ‘practice’, or in experiments in which a nonliving replica could be used, simply because they are available and convenient.

Scientists have a tendency to see their research as the most important endeavor, but these workers need to realize that there is a large group of people who find their actions difficult to stomach, and if they continue to act in a cavalier fashion, they may find their research opportunities curtailed even further.

Gloria

There are websites devoted to exposing the scientific FRAUD of animal experiments.Always when YDN’s covers this topic they avoid the efficicacy question entirely! It would be great to see Yale’s students host a debate based on pure science ONLY. Just watch how difficult it would be to get compliance from any Yale “researchers” to show up on behalf of human patients and explain why they STILL use the animal-model in their research. There is NEW evidence which proves the downright invalidity anf FRAUD of this useless and wasteful methodolgy. Go to http://www.curedisease.com and .net and see. In science the burden of proof is always placed on the person practicing a test, experiment, or procedure to show some sort of predictive value. To date 22 Yale researchers who use animals have refused to validate the authenticity of the work. Why? It is truely about salaries and careers and grants to which Yale handsomely profits from after expenses to the tune of 50-$75 million dollars. There are factual errors in the above story: ie: insulin and dogs is akin to crediting the cure of hunger to cows because a hamburger supplies nutrition and calorie needs. Also, crediting anti-biotics to animals is also wrong as well. The myths perpetuated by this “industry” is all about maintaining the status quoa. The students at the University of Wisconsin hosted a debate a few years ago based soley on science but Yale WON’T!!!